MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SYSTEM; SHOULDER LINER

Model Number	04.01.0123
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	09/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 23-sept-2024.Lot 2311719: (b)(4) items manufactured and released on 23-aug-2023.Expiration date: 2028-08-02.No anomalies found related to the problem.To date, 41 items of the same lot have been sold with no similar reported event during the period of review.Other devices involved: reverse shoulder system lat.Glenosphere 39xø27 (k193175) lot 2318705: (b)(4) items manufactured and released on 12-dec-2023.Expiration date: 2028-11-26.No anomalies found related to the problem.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At about 6 months after the primary, the patient came in reporting pain due to a dislocation of the liner from the glenosphere.The surgeon revised the glenosphere, liner and metaphysis.The surgery was completed successfully.

• Brand Name: SHOULDER SYSTEM
• Common Device Name: SHOULDER LINER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 20485245
• Report Number: 3005180920-2024-00822
• Device Sequence Number: 4095700
• Product Code: PHX
• UDI-Device Identifier: 07630040706308
• UDI-Public: 07630040706308
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.01.0123
• Device Lot Number: 2311719
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White